Exactech Recalls Alteon Neck Preserving Stems Due to Incorrect GTIN Labels
Exactech is recalling 98 Alteon Neck Preserving Stems because they were labeled with incorrect Global Trade Item Numbers (GTINs) that identify them as different devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect GTIN) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Exactech, Inc. is recalling 98 units of the Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6. The recall was initiated because the products were labeled with incorrect Global Trade Item Numbers (GTINs). The GTIN on the label incorrectly identifies the devices as another product.
The affected devices are identified by Catalog No. 162-00-06 and UDI 10885862262776. Specific serial numbers involved in the recall include 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-4420644, and 4558261-4458262. The devices were distributed to facilities in Arizona, California, Colorado, Florida, Illinois, Kansas, Maryland, New Jersey, New York, Ohio, Oklahoma, Tennessee, and Virginia, as well as in Germany, Italy, Japan, Spain, and Switzerland.
This recall is classified as Class II by the FDA. The source text does not report any illnesses or injuries associated with this labeling error. Healthcare providers and facilities should verify the GTINs on their inventory against the provided serial numbers and contact Exactech for further instructions.
The recalled product
- Product
- Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 98
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Serial No. 3787445-3787447
- 3868023-3868072
- 4209114-4209135
- 4318092-4318102
- 4350860-4350869
- 4386939
- 4420620-4420644
- 4558261-4458262
- Catalog No. 162-00-06
- UDI: 10885862262776
Distribution
Part of a larger recall action
This product is one of 3 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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